Kornimate/medical-research-clean huggingface dataset:
user performance evaluation of contour® next one, accu-chek® aviva connect, freestyle freedom lite, onetouch® verio and glucomen® areo blood glucose monitoring systems following iso 15197:2013

Conditions: Diabetes Mellitus

Summary: the user performance evaluation shows whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system. in this study, user performance evaluation will be performed for contour® next one (ascensia diabetes care gmbh), accu-chek® aviva connect (roche diabetes care gmbh), freestyle freedom lite (abbott diabetes care inc.), onetouch® verio (lifescan europe) and glucomen® areo a. menarini diagnostics s.r.l. (based on iso 15197:2013; en iso 15197:2015, clause 8. for each bgms, measurement procedures for user performance evaluation will be performed with 1 test meter and 1 reagent system lot by the study subjects. the same meter and an additional test meter will be used for double measurements performed by study personnel (with the same reagent system lot used by subjects).


Eligibility criteria:
inclusion criteria: * male or female, with type 1 diabetes, type 2 diabetes or subjects without diabetes * signed informed consent form * minimum age of 18 years * subjects are legally competent and capable to understand character, meaning and consequences of the study. * if blood glucose values \ 300 mg/dl shall be measured after short term alteration in insulin therapy: * male or female with type 1 diabetes and intensified insulin therapy or insulin pump therapy. * signature of subjects to document consent with these procedures on informed consent form. exclusion criteria: * pregnancy or lactation period * severe acute disease (at the study physician's discretion) * severe chronic disease with potential risk during the test procedures (at the study physician's discretion) * current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion) * being unable to give informed consent * \< 18 years * legally incompetent * being committed to an institution (e.g. psychiatric clinic) * language barriers potentially compromising an adequate compliance with study procedures * dependent on investigator or sponsor * if blood glucose values \< 80 mg/dl shall be measured after short term alteration in insulin therapy, subjects with type 1 diabetes, suffering from: * coronary heart disease * condition after myocardial infarction * condition after cerebral events * peripheral arterial occlusive disease * hypoglycemia unawareness
therapeutic assistance and decision-making algorithms in hepatobiliary tumor boards

Conditions: Hepatocellular Carcinoma; Fibrolamellar Hepatocellular Carcinoma; Cholangiocarcinoma, Perihilar; Intrahepatic Cholangiocarcinoma; Metastasis to Liver; Gallbladder Carcinoma

Summary: the goal of this observational study is to compare the recommendations of the artificial intelligence clinical decision support system 'adboard', with the recommendations of physicians by tumor conferences in patients with hepatobiliary tumors. the main questions it aims to answer are: can adboard achieve a high level of similar recommendations as physicians' tumor conferences? can adboard consider a more complete set of patient-related data than in physicians' tumor conferences? can adboard reduce the time between the first time the patient is discussed at the tumor conference and the start of the recommended treatment plan? participants will have their hepatobiliary tumor treatments determined by either tumor conference with adboard, or tumor conference without adboard.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * valid informed consent * patient information available in the hospital information system or health data platform (hdp) * enrollment in the hepatobiliary tumor conference * diagnosis of any of the following entities: colorectal liver metastasis, gallbladder carcinoma, hepatocellular carcinoma (hcc), mixed cell carcinoma, or fibrolamellar carcinoma, perihilar cholangiocarcinoma (klatskin tumors), intrahepatic cholangiocarcinoma (icc) exclusion criteria: * patient does not consent / incapable of giving consent * missing findings in the hospital information system * patient is seeking for a second opinion and is not being treated at the study institution

Keywords: decision support systems, clinical tumor conference tumor board multidisciplinary team meeting artificial intelligence machine learning natural language processing
observational study evaluating the safety of adasuve® in agitation associated with schizophrenia or bipolar i disorder

Conditions: Agitation,Psychomotor

Summary: this postmarketing observational study will evaluate the safety of adasuve® in treating patients with agitation associated with schizophrenia or bipolar i disorder.

this is a multicenter, prospective, observational study conducted to evaluate the safety of adasuve treatment when used in real-world clinical setting in patients with agitation associated with schizophrenia or bipolar i disorder. the primary objective of the study is to assess the safety of adasuve treatment in real-world clinical settings. the secondary objective of the study is to describe the characteristics of patients, including demographic and baseline characteristics, after administration of adasuve treatment in real-world clinical settings. the study population will consist of a non-randomized cohort of approximately 10000 adult men and women who have agitation associated with schizophrenia or bipolar i disorder (naïve and non-naïve to adasuve treatment).

Eligibility criteria:
inclusion criteria: patients may be included in the study if they meet all of the following criteria: 1. the patient is a man or woman who is 18 years of age or older at time of enrollment. 2. the patient is receiving adasuve for agitation in a medical or psychiatric emergency setting or in a psychiatric inpatient setting. (note: patients with a prior history of treatment with adasuve may also be included in the study.) 3. the patient (or caregiver or legally authorized representative) is willing and able to provide written informed consent (and assent, where applicable) after administration of adasuve treatment. exclusion criteria: there are no exclusion criteria for this study.

Keywords: agitation schizophrenia bipolar i disorder
neoadjuvant chemotherapy of primary breast cancer with epirubicin/docetaxel and carboplatin/docetaxel

Conditions: Primary Breast Cancer

Summary: the purpose of this study is to optimize results in neoadjuvant chemotherapy of local advanced primary breast cancer. therefore patients become first 3 cycles of epirubicin/docetaxel followed by 3x carboplatin/docetaxel.

most of the women who are diagnosed with breast cancer are in the situation that an operation is possible. using a neoadjuvant therapy the rate of breast-conserving surgery can be extended and tumor cell proliferation may be inhibited. further the neoadjuvant chemotherapy is an in-vivo-activity-test for the used drugs. epirubicin, docetaxel and carboplatin have shown antineoplastic activity against solid cancer alone and in combination. using two different combinations of these three drugs, first 3 cycles epirubicin/docetaxel and then changing to carboplatin/docetaxel for 3 further cycles it is assumed that the results of the therapy will improve. main criterion is the determination of pcr, second criteria are the rate of breast-conserving surgery, tumor response and therapy-dependent toxicities.

Eligibility criteria:
inclusion criteria: * histologically assured breast cancer * age \>= 18 years * bone marrow function: neutrophils \>= 1.5x109/l, platelets \>= 100x109/l, hemoglobin \>=6.2 mmol/l * sufficient renal and liver function * ecog 0-2 * written informed consent exclusion criteria: * pregnant or nursing women * distant metastases * t2-tumour \< 3cm and g1 * existing motoric or sensoric neurotoxicity \> grade 2 * known hypersensitivity against epirubicin or other anthracycline or against carboplatin or other platin derivatives or against docetaxel or against substances in the preparing solutions
study of fazirsiran (tak-999, aro-aat) in patients with alpha-1 antitrypsin deficiency associated liver disease (aatd)

Conditions: Alpha 1-Antitrypsin Deficiency

Summary: the purpose of this study is to evaluate the the safety and efficacy of the investigational product, fazirsiran (tak-999, aro-aat), administered subcutaneously to patients with alpha-1 antitrypsin deficiency associated liver disease (aatd).

participants will be enrolled to receive multiple subcutaneous injections of fazirsiran (tak-999, aro-aat). all eligible participants will require a pre-dose biopsy completed as part of the study within the screening window. all participants will undergo an end of study (eos) biopsy. treated participants will be offered the opportunity to continue treatment in an open label extension during which they will undergo a final biopsy.

Eligibility criteria:
inclusion criteria: * diagnosis of aatd * liver biopsy indicating metavir f1-f3 liver fibrosis based on local pathology read. * women of childbearing potential must have a negative pregnancy test, cannot be breast feeding, and must be willing to use contraception * willing to provide written informed consent and to comply with study requirements * non-smoker for at least 1 year * no abnormal finding of clinical relevance at screening exclusion criteria: * clinically significant health concerns other than aatd * previous diagnosis or diagnosis at screening of definitive liver cirrhosis * regular use of alcohol within one month prior to screening * use of an investigational agent or device within 30 days prior to dosing or current participation in an investigational study involving therapeutic intervention * use of illicit drugs within 1 year prior to screening note: additional inclusion/exclusion criteria may apply, per protocol
the natural history of human stingray injuries

Conditions: Stingray Injury; Marine Envenomation

Summary: stingray injuries can be a hazard shared by many types of beachgoers. stingrays often lie in the sand and when stepped on by the unsuspecting beachgoer their tail snaps foreword, resulting in a barbed stinger injecting venom into the victim. little exists in the current literature on the natural history of stingray injuries. most of the existing literature looks at the incidence of stings, and to a certain extent the demographic of people who seek care. to our knowledge no study has attempted to collect a more inclusive population of those people who are stung and follow them prospectively to determine the incidence of medical intervention, infection, etc. this study aims to describe and quantify the natural history of stingray injuries and to better understand their time course and medical requirements. the study setting will be seal beach, which reports some of the greatest number of annual stingray injuries for any single beach on the pacific coast. participants will be identified by the seal beach lifeguards who are believed to treat the majority of stingray injuries suffered at the beach. eligible persons will be consented for participation over the phone by research personnel. if enrolled in the study they will receive a phone call by research personnel one week and one month after the injury that will collect information about the symptoms they have experienced and the medical interventions they have received, if any. this study is strictly observational in nature and will not involve any interventions on the part of study personnel or alter the manner in which or types of medical assessments or treatments.


Eligibility criteria:
inclusion criteria: * people at seal beach, california * people identified by life guard personnel as being stung by a stingray at seal beach * adults or * children whose parent or guardian are present at the time of the injury exclusion criteria: * people who have previously been enrolled in the study * people who the lifeguard believes were stung or bit by a marine organism other than a stingray or a terrestrial organism
a comparison of two ab interno procedures in the treatment of glaucoma in patients undergoing cataract extraction

Conditions: Open Angle Glaucoma

Summary: the purpose of this study is to compare the safety and efficacy of goniotomy performed with a novel ophthalmic knife compared to trabecular bypass stent implantation in mild to moderate glaucoma subjects who are also undergoing cataract extraction with phacoemulsification (phaco) and posterior chamber intraocular lens (pciol) implant.


Eligibility criteria:
inclusion criteria: * diagnosis of open angle glaucoma (including pseudoexfoliation and pigmentary glaucoma) * diagnosis of mild to moderate glaucoma as defined by icd-9 staging definitions 365.71 mild/365.72 moderate (including visual field defects and/or characteristic optic nerve abnormalities consistent with mild to moderate glaucoma) * planned removal of a visually significant cataract as determined by the investigator (cortical, nuclear, subcapsular, or a combination) by manual phacoemulsification cataract extraction exclusion criteria: * any glaucoma diagnosis other than those noted in inclusion criteria

Keywords: glaucoma glaucoma surgery ab interno
delayed colorectal cancer care during coronavirus disease (covid-19) pandemic (decor-19)

Conditions: Colo-rectal Cancer; Colon Cancer; Rectal Cancer; Oncology; Surgery

Summary: to understand and analyse the global impact of covid-19 on outpatient services, inpatient care, elective surgery, and perioperative colorectal cancer care, a delayed colorectal cancer surgery (decor-19) survey was conducted in collaboration with numerous international colorectal societies with the objective of obtaining several learning points from the impact of the covid-19 outbreak on our colorectal cancer patients which will assist us in the ongoing management of our colorectal cancer patients and to provide us safe oncological pathways for future outbreaks.


Eligibility criteria:
inclusion criteria: * members of renowned scientific societies with an interest in coloproctology exclusion criteria: * none
vietnam head injury study - phase iii

Conditions: Traumatic Brain Injury; Penetrating Head Injury; Closed Head Trauma

Summary: the vietnam head injury study (vhis)-phase iii is a prospective, long-term follow-up study of head-injured vietnam veterans. the purpose of this research study is to determine the long-term consequences, if any, of head injury.

the vhis - phase iii evaluation to be conducted approximately 30 years post-injury will be devoted to examining, cutting-edge cognitive neuroscience issues and will utilize state of the art technologies to address basic research questions in the following areas: (1) functions of the human prefrontal cortex; (2) cognitive neuroplasticity in the aging brain; (3) memory; (4) long-term behavioral and psychosocial outcome; and (5) neurological studies, including an evaluation of post-traumatic epilepsy and repeat clinical measures from phase - ii. this testing will be complemented with structural neuroimaging, electroencephalogram (eeg) and molecular genetics. the goals of the vhis - phase iii include providing clinicians and scientists new insights into the long term recovery of function following brain injury, the role of the prefrontal cortex in executive functions, better predictors of long term outcome (including cognitive, neurological, and genetic factors), and the effects of head injury incurred in youth on aging and the development of dementia.

Eligibility criteria:
the researchers are seeking healthy control participants. inclusion criteria: * vietnam veteran * served in active combat between 1966 - 1971 * male exclusion criteria: * any medical condition that would make participation detrimental to the control (i.e.: severe clinical depression, acute heart dysfunction, etc...) * a history of severe head injury, stroke, loss of consciousness, or other significant neurological, psychiatric or medical condition that would render the subject unsuitable for the vhis testing battery.

Keywords: traumatic brain injury penetrating head wound closed head trauma vietnam veteran
3 year recurrence free survival in ultra-low-risk endometrial cancer

Conditions: Endometrial Cancer

Summary: to verify the safety of omission of lymph node dissection in ultra-low-risk endometrial cancer (kgog criteria), we examine the survival of women with ultra-low-risk endometrial cancer who do not undergo lymph node dissection


Eligibility criteria:
inclusion criteria: * endometrioid type * anticipated surgery omitting lymph node dissection for endometrial cancer * pelvis mri, ca125 - satisfying kgog criteria * no distant metastasis * age 19 or more exclusion criteria: * other cancer within 5 yr * previous hysterectomy * previous therapy for endometrial cancer
low dose aspirin in the prevention of preeclampsia in china

Conditions: Preeclampsia

Summary: preeclampsia is one of the three leading causes of maternal morbidity and mortality all over the world. the use of low dose aspirin has been mentioned in several studies with promising results. the investigators decided to evaluate the use of low dose aspirin in chinese pregnant women, starting between 12+ and 20 weeks of pregnancy, based on clinical characteristics aiming to reduce the incidence of preeclampsia.

detailed description: the investigators will conduct a randomized control trial to estimate the efficacy of low dose aspirin in preventing preeclampsia in chinese pregnant women who are evaluated with risk factors. the investigators will also obtain biological specimen including maternal blood, cord blood, placenta specimen and etc. for basic science studies. rationale for design:there is a lack of evidences or guideline of aspirin using in preventing pe for chinese women. the investigators will conduct a randomized control trial, which is the 'gold standard' of research design, hoping to answer the question.

Eligibility criteria:
inclusion criteria: 1. gestational age between 12+ and 20 weeks of pregnancy 2. high risk of preeclampsia, based in clinical risk factors as: 2.1 if they have one or more of the following risk factors： preeclampsia in a previous pregnancy ,diabetes mellitus(type 1 or 2),chronic hypertension . 2.2 if they have two or more of the following risk factors: pre-pregnancy body mass index ≥28kg/m2, elderly pregnancy(age ≥35 years), mother or sisters with preeclampsia in a previous pregnancy, primiparity or famliy history (mother or sister that developed preeclampsia in a previous pregnancy）. 3. signed informed consent. exclusion criteria: 1. allergy to aspirin 2. asthma 3. peptic ulcers 4. severe heart, liver, renal disease who can not burden the experiment 5. rheumatic immune disease 6. mental disease 7. alcohol and drug abuse 8. being in another drug experiment within 3 months 9. difficult to follow-up

Keywords: preeclampsia low dose aspirin prevention
study of stomatognathic system of the obese subjects

Conditions: Obesity

Summary: the aim is to identify differences in the stomatognathic system, mastication and deglutition functions between obese and normal weight subjects.

the aim of this study was to identify differences in the stomatognathic system between obese and normal weight subjects. the habitual chewing of a french bread and deglutition of solids and liquid was evaluated five times in obese subjects and controls. the tonus of the lips, tongue, cheeks, masseter and temporal muscles were evaluated by clinical observation and palpation and defined as either normal or reduced. twenty obese patients (body mass index (bmi) \> 30kg/m2) and twenty volunteers of normal weight (bmi 18.5-24.9 kg/m2) were evaluated.

Eligibility criteria:
inclusion criteria: * healthy adults male and female * healthy dentate * body mass index (bmi) higher than 30 kg/m2 for the obesity group and (bmi) lower than 25/m2 for the normal weight group. exclusion criteria: * face deformity * alterations in morphology of lips and tongue * without teeth or with lack of one tooth (excluding third molars) * malocclusion angle's class ii and iii * pain during chewing * pathology of the temporomandibular joint * neurological pathology

Keywords: chewing deglutition orofacial motricity obesity
clinical evaluation of a daily wear silicone hydrogel lens

Conditions: Refractive Errors; Myopia; Hyperopia

Summary: the purpose of this clinical study is to assess the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality with frequent replacement.

subjects will attend 4 office visits: screening/baseline/dispense; week 1 follow-up; month 1 follow-up; and month 3 follow-up/exit. the total expected duration of participation for each subject is approximately 3 months.

Eligibility criteria:
key inclusion criteria: * understand and sign an irb/iec approved informed consent form. * willing and able to attend all scheduled study visits and wear the assigned study lenses as required per protocol. * successful wear of frequent replacement, spherical, daily wear soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day. * manifest cylinder ≤ 0.75 diopter (d) in each eye. * best spectacle corrected visual acuity 20/20 or better in each eye. * other protocol-defined inclusion criteria may apply. key exclusion criteria: * wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment. * monovision contact lens wear. * any habitual wear of biofinity lenses. * other protocol-defined exclusion criteria may apply.

Keywords: contact lenses
is high intensity interval training effective to reduce the waist circumference and fat percentage at trunk region

Conditions: Overweight; Physically Inactive; Adults

Summary: overweight is a risk factor for a number of non-communicable diseases, and this risk doubles, if an individual is physically inactive. various exercise interventional protocols in the past have been reported on treating overweight and obesity which helps to decrease the different anthropometric variables. despite all these protocols, obese and overweight do not seem to benefit greatly by these exercise training programs, as lack of time is thought to the main reason for not engaging in healthful physical exercise. research evidence has proven that people with a body mass index of more than 30 kg/m2 and waist circumference of more than 102 cm have 2-fold higher risk of waking fewer steps daily. although physical exercise is thought to be very helpful in regulating the body weight, it is very important to identify the type of physical activity to effectively manage overweight and obesity. aerobic exercise namely high intensity interval training have been reported to reduce the body mass, fat%, and waist circumference. investigators believe that high intensity interval training would help in controlling the various anthropometric variables namely the body mass index, waist circumference, and fat% in trunk region in physically inactive overweight adults.


Eligibility criteria:
inclusion criteria: * either gender * aged 18-25 years * physically inactive exclusion criteria: * any medical condition that restrict the participants to participate in physical exercise * blood pressure of more than 140/90 mmhg * participants taking any medication that causes drowsiness